Citius Pharmaceuticals Resubmits BLA to FDA for Lymphir to Treat Cutaneous T-Cell Lymphoma
March 19th 2024Pivotal Phase III Study 302 trial data show an objective response rate of 36.2% based on an independent review committee assessment in the treatment of relapsed/refractory cutaneous T-cell lymphoma.
Phase III THARROS Trial to Evaluate Impact of Breztri Aerosphere on Cardiopulmonary Outcomes in COPD
March 14th 2024THARROS trial investigators seek to provide first-of-its-kind evidence supporting a strategy of comprehensive cardiopulmonary risk reduction with a triple therapy in patients with chronic obstructive pulmonary disease.
Results of Phase III Trial Show Promise of Potential First-in-Class Treatment for Dry Eye Disease
February 28th 2024PL9643 ophthalmic solution is a melanocortin agonist with a novel mechanism of action that produced a clinically meaningful and statistically significant reduction in pain associated with dry eye disease.
FDA Approves New Biweekly Reduced Dosing of Tecvayli Based on Phase I/II MajesTEC-1 Trial Data
February 21st 2024The Phase I/II MajesTEC-1 trial (NCT03145181; NCT04557098) evaluated Tecvayli (teclistamab-cqyv) at a reduced dose of 1.5 mg/kg administered every two weeks in patients with relapsed/refractory multiple myeloma.
Phase III INDIGO Trial Data Lead to FDA Priority Review for Vorasidenib in IDH-Mutant Gliomas
February 20th 2024Data from the pivotal, global, randomized, double-blind, placebo-controlled, Phase III INDIGO trial show statistically significant and clinically meaningful progression-free survival for vorasidenib treating IDH-mutant gliomas.
Phase III OUtMATCH Trial Findings Lead to FDA Approval of Xolair to Treat Multiple Food Allergies
February 16th 2024In clinical trials, Xolair was found to significantly increase the amount of peanuts, milk, egg, and cashew that it takes to trigger an allergic reaction in participants with food allergies.
FDA Upgrades Tepmetko to Full Approval for Metastatic NSCLC Based on VISION Trial Data
February 16th 2024Single-arm, open-label, multicenter, non-randomized, multicohort Phase II VISION trial (NCT02864992) of Tepmetko (tepotinib) for metastatic non–small cell lung cancer shows favorable objective response rate.